meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
1994-11-30

Clearances · page 114 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K944987 URO - ELITE TABLE ACCESSORIES Philips Medical Systems (Cleveland), Inc. IXR Class II 1994-11-30
K941223 ADVANCE ANALYSIS SOFTWARE General Electric Co. KPS Class II 1994-11-29
K943320 HEAD AND NECK COIL FOR THE GYREX 2T-DLX Elscint, Inc. LNH Class II 1994-11-29
K944983 MEDRAD COUNTERPOISE SYSTEM Medrad, Inc. JAK Class II 1994-11-29
K943447 V-MAX OPTIONS Philips Medical Systems (Cleveland), Inc. JAA Class II 1994-11-28
K943926 RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE Philips Medical Systems (Cleveland), Inc. IZZ Class II 1994-11-28
K943383 IMAGING WORKBENCH Brit Systems, Inc. LMD Class I 1994-11-22
K943357 CEMAX SCANLINK V Cemax, Inc. LMA Class II 1994-11-22
K945039 MCI OPTONIX CASSETTE OKAMOTO CASSETE Mci Optonix, Inc. IXA Class II 1994-11-22
K943158 AD/V IMAGEPLEX(TM) Adaptive Video, Inc. LMD Class I 1994-11-22
K944315 BLOCKING TRAY Medtec, Inc. IYE Class II 1994-11-22
K940534 GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) Philips Medical Systems, Inc. LNH Class II 1994-11-22
K940671 INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER Interspec, Inc. ITX Class II 1994-11-22
K940664 PAPER FILM Astro Office Products, Inc. LLZ Class II 1994-11-15
K940151 ULTRASOUND PROBE DRAPE Hydro-Med Products, Inc. IYO Class II 1994-11-14
K942917 ULTRAPRO WORKSTATION Ramsoft, Inc. LMD Class I 1994-11-14
K931021 SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. Shimadzu Medical Systems IYO Class II 1994-11-14
K941093 SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION Smartpacs LLZ Class II 1994-11-07
K940541 MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF) Siemens Medical Solutions USA, Inc. LNH Class II 1994-11-07
K943355 GEMNET GE Medical Systems IZI Class II 1994-11-07
K935428 BENNETT X-RAY DIGITAL SPOT IMAGER Bennett X-Ray Technologies IZH Class II 1994-11-01
K930964 ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) Acuson Corp. IYO Class II 1994-10-26
K935427 R AND D BATTERIES R & D Batteries, Inc. JAF Class II 1994-10-21
K934915 ACUSON MODEL 2001 Acuson Corp. IYN Class II 1994-10-21
K941652 ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION Aloka Co., Ltd. IYN Class II 1994-10-21
K944326 PHILIPS TOMOSCAN SR5000 Philips Medical Systems North America, Inc. JAK Class II 1994-10-21
K944772 MULTIPLE ED1600 SERIES RADIATION SHIELDS Image Diagnostics, Inc. EAK Class I 1994-10-20
K932760 DFS-2100 Dba Systems, Inc. LMA Class II 1994-10-20
K933743 SSA-380A Toshiba America Medical Systems, In.C IYN Class II 1994-10-20
K936087 CARPAL BOX Innovative Medical Technologies, Inc. KPR Class II 1994-10-20
K934868 LORAD TRANSPO Lorad Corp. IZH Class II 1994-10-14
K943021 MRT-150A Toshiba America Mri, Inc. LNH Class II 1994-10-14
K942731 SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR Shimadzu Corp. IZO Class I 1994-10-13
K935009 PEGASUS Advanced Technology Laboratories, Inc. IYN Class II 1994-10-11
K936272 PHILIPS TOMOSCAN SR 4000 Philips Medical Systems North America, Inc. JAK Class II 1994-10-11
K926008 PINNACLE 3 Adac Laboratories IYE Class II 1994-10-04
K933916 AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER Ausonics Pty , Ltd. IYN Class II 1994-10-03
K925999 SWEMED NEEDLE GUIDE Swemed Lab Intl. IYO Class II 1994-10-03
K942953 ORACLE MRI WHOLE BODY MR IMAGING SYSTEM Otsuka Electronics USA, Inc. LNH Class II 1994-09-30
K942883 DIGITAL I.D. CAMERA Miles Inc., Agfa Division JAC Class I 1994-09-30
K943634 HP 77010CF Hewlett-Packard Co. IYO Class II 1994-09-30
K940487 ISOCAM II (DUAL HEAD GAMMA CAMERA) Independent Scintilation Imaging Systems, Inc. KPS Class II 1994-09-30
K931909 CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL Sonomed Technology, Inc. IYO Class II 1994-09-29
K940172 CARDIOVASCULAR MEASUREMENT SYSTEM-CMS Medis Medical Imaging Systems, Inc. IZI Class II 1994-09-29
K931908 SONOQUICK ULTRASOUND GEL Sonomed Technology, Inc. IYO Class II 1994-09-29
K943072 BETA C COUNTER Capintec Instruments, Inc. KPT Class II 1994-09-29
K934040 THE OSTEOREPORT Woodson and Associates, LLC KGI Class II 1994-09-26
K932501 VARIAN ORIGAMI, VERSION 1.0 Varian Assoc., Inc. IYE Class II 1994-09-23
K936001 PATLAK & FDG AUTORADIOGRAPHIC GE Medical Systems KPS Class II 1994-09-23
K930513 VARIAN RMS-2000, RELEASE 2.5 Varian Assoc., Inc. IYE Class II 1994-09-23
K943805 PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD General Electric Co. JAA Class II 1994-09-23
K926019 FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET Norland Corp. KGI Class II 1994-09-23
K942146 PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER Siemens Medical Solutions USA, Inc. KPS Class II 1994-09-23
K943321 QUAD PELVIS COIL Hitachi Medical Systems America, Inc. LNH Class II 1994-09-23
K934041 HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION Hewlett-Packard Co. IYN Class II 1994-09-22
K933430 CYTOGUIDE STEREOTATIC BIOPSY SYSTEM Gold Coast Imaging, Inc. IZH Class II 1994-09-22
K936152 3M 1152 LASER IMAGER 3M Information,Imaging and Electronic Sector LMC Class II 1994-09-21
K942776 MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1 Otsuka Electronics USA, Inc. LNH Class II 1994-09-21
K941546 SOMATOM PROJECT 059 Siemens Corp. JAK Class II 1994-09-20
K934987 CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX Elscint, Inc. LNH Class II 1994-09-16
K944150 MICRO X-65 HF Fischer Imaging Corp. IZO Class I 1994-09-16
K944149 MICRO X-80 HF Fischer Imaging Corp. IZO Class I 1994-09-16
K944148 MICRO X-30HF Fischer Imaging Corp. IZO Class I 1994-09-16
K941600 MT-300 CASSETTE HOLDER Medtec, Inc. IXA Class II 1994-09-16
K942860 VISIONLINK DICOM MODULE Evergreen Technologies, Inc. KPS Class II 1994-09-16
K944147 MICRO X-50 HF Fischer Imaging Corp. IZO Class I 1994-09-16
K942363 CEQUAL-QUANTITATIVE ANALYSIS Nuccardiac Software, Inc. KPS Class II 1994-09-16
K942355 MODEL #310T03500 WRIST COIL Medic, Inc. LNH Class II 1994-09-16
K936142 3M 1154 LASER IMAGER 3M Information,Imaging and Electronic Sector LMC Class II 1994-09-16
K924685 STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM Leibinger GmbH IYE Class II 1994-09-16
K931071 PHILIPS THORAVISION Philips Medical Systems, Inc. KPR Class II 1994-09-15
K932672 MAMMOMAT 300 AND MAMMOMAT 3000 Siemens Medical Solutions USA, Inc. IZH Class II 1994-09-14
K932106 MOBILETT PLUS MOBILE X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZL Class II 1994-09-14
K942560 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. LNH Class II 1994-09-09
K936002 CINEMAC QAS Xre Corp. IZI Class II 1994-09-09
K942916 OCTOPAQUE UNIVERSAL Octostop, Inc. IXQ Class II 1994-09-08
K940306 OCTOSTOP COMPENSATING FILTERS Octostop, Inc. KPR Class II 1994-09-06
K935444 OCTOSTOP(R) CHAIR (NEW MODEL Octostop, Inc. IXR Class II 1994-09-02
K940632 I-125 RAPID STRAND Medi-Physics Inc. Dba Nycomed Amersham Imaging IWI Class II 1994-09-02
K942609 MRT-150A SHOULDER COIL Toshiba America Mri, Inc. LNH Class II 1994-09-02
K942083 ADVANCED THERAPY DOSIMETER Keithley Instruments, Inc. IYE Class II 1994-09-02
K940894 MAGNA SL Magna-Lab, Inc. LNH Class II 1994-09-02
K930506 THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM Pinecliff Assoc. IYE Class II 1994-08-29
K936179 WINRAD TELERADIOLOGY SYSTEM Line Imaging Systems LLZ Class II 1994-08-25
K941996 EDGE Philips Medical Systems (Cleveland), Inc. LNH Class II 1994-08-25
K935549 GYREX 2T-SGR Elscint, Inc. LNH Class II 1994-08-24
K935026 DIGITAL MEDIA CONVERTER (D-MC) Eigen Video IZI Class II 1994-08-24
K934831 ADVANCED AUTOMATIC KV Elscint, Inc. IZH Class II 1994-08-23
K940796 ACCESS Toshiba America Mri, Inc. LNH Class II 1994-08-23
K942441 IMEXDOP CT+ Imex Medical Systems, Inc. JAF Class II 1994-08-23
K940606 HISPEED ADVANTAGE II GE Medical Systems JAK Class II 1994-08-23
K934318 DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL Diagnostic Instrument Corp. LNH Class II 1994-08-22
K940295 UROVIEW MODEL 2600 Ge Dec Medical Systems JAA Class II 1994-08-22
K943823 FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-08-22
K943821 KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-08-22
K943822 FUJI UM MAMMO SERIES INTENSIFY SCREENS: Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-08-22
K943652 VASCULAR MP X-RAY GENERATOR GE Medical Systems IZO Class I 1994-08-22
K942190 ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE Image Diagnostics, Inc. IXQ Class II 1994-08-17
K943504 RSX-525HF Fischer Imaging Corp. IZO Class I 1994-08-17
K942175 LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 Continental X-Ray Corp. IZF Class II 1994-08-17

14,721 clearances in the Radiology panel. Data: openFDA.